Participant Information, Consent Form and Waiver
Title: VeboLife program on cognitive mapping stimulation towards a healthy cognition and a healthy hippocampus.
General Purpose: Empowering participants by self-management and better health outcomes via VeboLife, a program based on cognitive mapping toward a healthy cognition and a healthy hippocampus. The VeboLife program is given by NeuroNautilus Inc. for whom you are signing this consent form and waiver.
Purpose of the Subject Information and Consent Form
The purpose of this form is to give you information about this program and, if you sign it, it means you will have agreed to participate. The form describes the purpose, procedures, benefits, risks and side effects involved. Please ask the personnel to explain any words or procedures that you do not clearly understand. You may refuse to take part or withdraw at any time.
Decades of unsuccessful pharmacological clinical trials aimed to treat neurological and psychiatric disorders associated with the hippocampus have proven to be exasperating and suggest that intervention protocols should be applied earlier than previously anticipated. These diseases form a social and economic burden. Interventions that aim to help these diseases are therefore a major public health imperative.
Atrophy of the hippocampus has been associated with cognitive deficits in normal aging and it predisposes individuals to various disorders such as post-traumatic stress disorder, schizophrenia, depression, ADHD, addiction and AD. As such, healthy cognition is often associated with a healthy hippocampus.
Dr. Bohbot’s research has shown that grey matter in the hippocampus significantly correlates with the use of spatial memory in children, young adults, and older adults. Furthermore, spatial memory training has proven to increase grey matter in the hippocampus of healthy older adults and adult mice, thereby reducing the risks of certain neurological and psychiatric disorders.
VeboLife is a program based on cognitive mapping toward a healthy cognition and a healthy hippocampus.
VeboLife will integrate the principles of cognitive mapping in an easy to follow interactive program focused on lifestyle changes to improve cognition and general health.
Purpose of the individual profiles
The purpose of the individual profile is for you to obtain information about your current situation associated with a healthy hippocampus, as well as whether this has changed after the VeboLife program.
We anticipate that this program will help increase chances of benefiting from a healthier lifestyle and increased well-being which can greatly improve quality of life and life expectancy.
Procedures in the VeboLife program:
- The VeboLife program will be installed on your computer device. It is a program that is given over a period of 6 weeks, for 2 hours per week for a total of 16 hours. With your computer, you will be asked to virtually navigate in environments where you will be asked to memorize the positions of objects.
- The individual profile involves filling out a health questionnaire as well as questions specific to your life style. The individual profile is about 60 minutes long in duration, both before and after the 8 week program, in order to help evaluate you before and after the program. The health questionnaire consists of`:
- Online spatial memory task to measure the functioning of your hippocampus. You will be invited to navigate in virtual environments to learn and remember the various places presented to you.
- General medical information associated with your individual profiles, questionnaires specific to your memory, attention, mood, and lifestyle.
Potential Risks and Discomforts:
By providing information through the health questionnaire before and after the program, you will be getting a better understanding of the usefulness of the VeboLife program as a potential tool for health improvement. If you have no known health problems, there is no known risk associated with participating in this program.
In previous years, there were a few cases of nausea during the navigation in the virtual environment presented on the computer. If you experience nausea during the virtual navigation task, you should stop the task immediately.
Confidentiality: Your confidentiality will be respected. Information that discloses your identity will not be released without your consent unless required by law or regulation. Information that directly discloses your identity will remain only with the NeuroNautilus Team. Information that could be used to “link” your identity (“Anonymous Identification”) will not be released without your knowledge or consent.
Access to the VeboLife program database is restricted by password to the staff working on the program.
Results from the VeboLife program and any information associated with it may be presented at scientific meetings or in medical journals; however, your identity will not be disclosed in any presentations.
The content of the VeboLife program is the sole property of NeuroNautilus Inc., or its licensors, and in participating in the current program, you agree to keep the information presented to you secret and confidential. You equally acknowledge that all anonymous results retrieved from this program belong exclusively to NeuroNautilus Inc.
Voluntary Participation and Withdrawal: You can refuse to participate or withdraw from the program at any time. Furthermore, coordinators reserve the right to cancel the program for any reason, at any time during the program. In all cases, this will have no impact on your health.
Refund Policy: Our refund policy involves:
— 100% of your money back if the refund request is made 10 days prior to first session
— 80% of your money back if the refund request is made 5 days prior to the first session
— 0% of your money back if the refund request is made less than 4 days prior to the first session.
Incidental findings: All incidental findings concerning your health will be communicated to you, and if requested, communicated to your doctor as well.
Legal Rights: By signing this consent form, you hereby waive all claims for any damage suffered of any kind, including but not limited to personal injury, against NeuroNautilus Inc. and the Douglas Institute, their employees, directors, administrators, shareholders, agents, sponsors, as well as against the principal researcher, the local researcher, and their employees, except in cases of negligence or gross fault.
If you have any questions regarding your rights as a participant in this program, you can contact Anja Bondroit at firstname.lastname@example.org
NeuroNautilus Inc. President:
Dr. Veronique Bohbot
Informed Consent Signature Page
Empowering participants by self-management and better health outcomes via VeboLife, a clinical patent pending program based on the cognitive mapping pillar to a healthy cognition and a healthy hippocampus.
- I understand that my participation in this program is voluntary.
- I have read all the pages of the consent form. The personnel have explained the information and procedures involved. I have had the opportunity to ask questions and my questions have been answered satisfactorily. I have been given time to consider the information carefully and to decide whether or not to participate in this program.
- I have been informed that my participation is entirely voluntary and that I may refuse to participate, or withdraw at any time.
- I will immediately stop the navigation task if I experience nausea, and I will inform the personnel of this.
- I understand that, other than cases of negligence or gross fault, I am waiving my legal rights by signing this form and am freeing the investigators, sponsors, and the health establishment where the program takes place from their civil and professional responsibilities.
- My signature below indicates that I voluntarily agree to take part.
- I understand that I will be given a copy of this informed consent to keep for my own information, once it is signed.